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Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

Primary Purpose

Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dabigatran
Warfarin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Inclusion_Criteria Acute symptomatic deep vein thrombosis (DVT) Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing Exclusion criteria: Exclusion_Criteria Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN Severe renal impairment (estimated creatinine clearance <= 30 ml/min)

Sites / Locations

  • 1160.47.01035 Boehringer Ingelheim Investigational Site
  • 1160.47.01056 Boehringer Ingelheim Investigational Site
  • 1160.47.01044 Boehringer Ingelheim Investigational Site
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  • 1160.47.61002 Princess Alexandra Hospital
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  • 1160.47.44012 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran

Warfarin (INR of 2.0-3.0)

Arm Description

Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements

Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily

Outcomes

Primary Outcome Measures

Composite of Recurrent VTE or VTE Death at 36 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Composite of Recurrent VTE or VTE Death at 18 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

Secondary Outcome Measures

Composite of Recurrent VTE or All Cause Death at 36 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Composite of Recurrent VTE or All Cause Death at 18 Months
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Deep Vein Thrombosis (DVT) at 36 Months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
DVT at 18 Months
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Symptomatic Pulmonary Embolism (PE) at 36 Months
Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Symptomatic Pulmonary Embolism (PE) at 18 Months
Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Deaths Related to VTE at 36 Months
Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Deaths Related to VTE at 18 Months
Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Deaths of All Causes at 36 Months
Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Deaths of All Causes at 18 Months
Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Number of Participants With Bleeding Events
MBE (major bleeding event) if it fulfilled at least one of the following criteria Fatal bleeding Symptomatic bleeding in a critical area or organ. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria Spontaneous skin haematoma ≥25 cm2 Spontaneous nose bleed >5 min duration Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h Spontaneous rectal bleeding Gingival bleeding >5 min Bleeding leading to hospitalisation or requiring surgical treatment Bleeding leading to a transfusion of <2 units of whole blood or red cells Any other bleeding event considered clinically relevant by the investigator
Laboratory Analysis
Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
Number of Participants With Definite Acute Coronary Syndrome (ACS)
All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.

Full Information

First Posted
May 23, 2006
Last Updated
May 8, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00329238
Brief Title
Secondary Prevention of Venous Thrombo Embolism (VTE).
Acronym
RE-MEDY
Official Title
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2867 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran
Arm Type
Experimental
Arm Description
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Arm Title
Warfarin (INR of 2.0-3.0)
Arm Type
Active Comparator
Arm Description
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Intervention Description
Dabigatran 150 mg BID (twice daily)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Warfarin dosed individually to maintain INR 2.0-3.0
Primary Outcome Measure Information:
Title
Composite of Recurrent VTE or VTE Death at 36 Months
Description
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time Frame
36 months
Title
Composite of Recurrent VTE or VTE Death at 18 Months
Description
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Composite of Recurrent VTE or All Cause Death at 36 Months
Description
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time Frame
36 months
Title
Composite of Recurrent VTE or All Cause Death at 18 Months
Description
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
Time Frame
18 months
Title
Deep Vein Thrombosis (DVT) at 36 Months
Description
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time Frame
36 months
Title
DVT at 18 Months
Description
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
Time Frame
18 months
Title
Symptomatic Pulmonary Embolism (PE) at 36 Months
Description
Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time Frame
36 months
Title
Symptomatic Pulmonary Embolism (PE) at 18 Months
Description
Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
Time Frame
18 months
Title
Deaths Related to VTE at 36 Months
Description
Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time Frame
36 months
Title
Deaths Related to VTE at 18 Months
Description
Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
Time Frame
18 months
Title
Deaths of All Causes at 36 Months
Description
Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time Frame
36 months
Title
Deaths of All Causes at 18 Months
Description
Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
Time Frame
18 months
Title
Number of Participants With Bleeding Events
Description
MBE (major bleeding event) if it fulfilled at least one of the following criteria Fatal bleeding Symptomatic bleeding in a critical area or organ. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells. Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria Spontaneous skin haematoma ≥25 cm2 Spontaneous nose bleed >5 min duration Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h Spontaneous rectal bleeding Gingival bleeding >5 min Bleeding leading to hospitalisation or requiring surgical treatment Bleeding leading to a transfusion of <2 units of whole blood or red cells Any other bleeding event considered clinically relevant by the investigator
Time Frame
first intake of study drug until 6 days following last intake of study drug
Title
Laboratory Analysis
Description
Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
Time Frame
18 months + 30 days follow up
Title
Number of Participants With Definite Acute Coronary Syndrome (ACS)
Description
All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
Time Frame
day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Inclusion_Criteria Acute symptomatic deep vein thrombosis (DVT) Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing Exclusion criteria: Exclusion_Criteria Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.47.01035 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
1160.47.01056 Boehringer Ingelheim Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
1160.47.01044 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1160.47.01019 Boehringer Ingelheim Investigational Site
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
1160.47.01008 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1160.47.01014 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1160.47.01018 Boehringer Ingelheim Investigational Site
City
Roxbury Crossing
State/Province
Massachusetts
Country
United States
Facility Name
1160.47.01023 Boehringer Ingelheim Investigational Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
1160.47.01009 Boehringer Ingelheim Investigational Site
City
St. Louis Park
State/Province
Minnesota
Country
United States
Facility Name
1160.47.01031 Boehringer Ingelheim Investigational Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
1160.47.01036 Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
1160.47.01027 Boehringer Ingelheim Investigational Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
1160.47.01039 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1160.47.01030 Boehringer Ingelheim Investigational Site
City
Grand Forks
State/Province
North Dakota
Country
United States
Facility Name
1160.47.01013 Boehringer Ingelheim Investigational Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
1160.47.01052 Boehringer Ingelheim Investigational Site
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
1160.47.01055 Boehringer Ingelheim Investigational Site
City
Summerville
State/Province
South Carolina
Country
United States
Facility Name
1160.47.01017 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1160.47.54017 Boehringer Ingelheim Investigational Site
City
Adrogué
Country
Argentina
Facility Name
1160.47.54015 Boehringer Ingelheim Investigational Site
City
Bahía Blanca
Country
Argentina
Facility Name
1160.47.54001 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1160.47.54003 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1160.47.54005 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1160.47.54006 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1160.47.54007 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1160.47.54010 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1160.47.54016 Boehringer Ingelheim Investigational Site
City
La Plata
Country
Argentina
Facility Name
1160.47.54014 Boehringer Ingelheim Investigational Site
City
Mar del Plata
Country
Argentina
Facility Name
1160.47.54013 Boehringer Ingelheim Investigational Site
City
Quilmes
Country
Argentina
Facility Name
1160.47.54011 Boehringer Ingelheim Investigational Site
City
Rosario
Country
Argentina
Facility Name
1160.47.54018 Boehringer Ingelheim Investigational Site
City
Salta
Country
Argentina
Facility Name
1160.47.54012 Boehringer Ingelheim Investigational Site
City
Santa Fe
Country
Argentina
Facility Name
1160.47.61002 Princess Alexandra Hospital
City
Wooloongabba
State/Province
Queensland
Country
Australia
Facility Name
1160.47.61004 Boehringer Ingelheim Investigational Site
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
1160.47.61003 Boehringer Ingelheim Investigational Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
1160.47.61001 Boehringer Ingelheim Investigational Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
1160.47.61006 Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Victoria
Country
Australia
Facility Name
1160.47.61005 Boehringer Ingelheim Investigational Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
1160.47.43001 Boehringer Ingelheim Investigational Site
City
Graz
Country
Austria
Facility Name
1160.47.43003 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
1160.47.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.47.43004 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.47.32001 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1160.47.32002 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1160.47.32005 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1160.47.32004 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1160.47.55010 Boehringer Ingelheim Investigational Site
City
Brasília
Country
Brazil
Facility Name
1160.47.55007 Boehringer Ingelheim Investigational Site
City
Campinas - SP
Country
Brazil
Facility Name
1160.47.55014 Boehringer Ingelheim Investigational Site
City
Curitiba
Country
Brazil
Facility Name
1160.47.55017 Boehringer Ingelheim Investigational Site
City
Juvene - Paraná -
Country
Brazil
Facility Name
1160.47.55012 Boehringer Ingelheim Investigational Site
City
pTO aLEGRE
Country
Brazil
Facility Name
1160.47.55016 Boehringer Ingelheim Investigational Site
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
1160.47.55018 Boehringer Ingelheim Investigational Site
City
São Bernardo do Campo
Country
Brazil
Facility Name
1160.47.55005 Boehringer Ingelheim Investigational Site
City
São José do Rio Preto
Country
Brazil
Facility Name
1160.47.35910 Boehringer Ingelheim Investigational Site
City
Plovdiv
Country
Bulgaria
Facility Name
1160.47.35908 Boehringer Ingelheim Investigational Site
City
Rousse
Country
Bulgaria
Facility Name
1160.47.35901 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.47.35903 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.47.35904 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.47.35906 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.47.35907 Boehringer Ingelheim Investigational Site
City
Sofia
Country
Bulgaria
Facility Name
1160.47.35905 Boehringer Ingelheim Investigational Site
City
Varna
Country
Bulgaria
Facility Name
1160.47.02006 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.47.02013 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1160.47.02021 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1160.47.02004 Boehringer Ingelheim Investigational Site
City
Saint Johns
State/Province
New Brunswick
Country
Canada
Facility Name
1160.47.02001 Boehringer Ingelheim Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
1160.47.02002 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.47.02005 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.47.02010 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.47.02022 Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
1160.47.02015 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1160.47.02019 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1160.47.02008 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.47.02009 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.47.02014 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.47.02017 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1160.47.86001 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1160.47.86015 Boehringer Ingelheim Investigational Site
City
Beijing
Country
China
Facility Name
1160.47.86014 Boehringer Ingelheim Investigational Site
City
Chengdu
Country
China
Facility Name
1160.47.86012 Boehringer Ingelheim Investigational Site
City
Guangzhou
Country
China
Facility Name
1160.47.86009 Boehringer Ingelheim Investigational Site
City
Hangzhou
Country
China
Facility Name
1160.47.86010 Boehringer Ingelheim Investigational Site
City
Hangzhou
Country
China
Facility Name
1160.47.86013 Boehringer Ingelheim Investigational Site
City
Nanjing
Country
China
Facility Name
1160.47.86002 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86003 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86004 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86005 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86006 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86007 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86016 Boehringer Ingelheim Investigational Site
City
Shanghai
Country
China
Facility Name
1160.47.86011 Boehringer Ingelheim Investigational Site
City
Shijiazhuang
Country
China
Facility Name
1160.47.42001 Boehringer Ingelheim Investigational Site
City
Brno
Country
Czech Republic
Facility Name
1160.47.42002 Boehringer Ingelheim Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
1160.47.42011 Boehringer Ingelheim Investigational Site
City
Hranice
Country
Czech Republic
Facility Name
1160.47.42012 Boehringer Ingelheim Investigational Site
City
Liberec
Country
Czech Republic
Facility Name
1160.47.42015 Boehringer Ingelheim Investigational Site
City
Novy Jicin
Country
Czech Republic
Facility Name
1160.47.42005 Boehringer Ingelheim Investigational Site
City
Ostrava-Vitkovice
Country
Czech Republic
Facility Name
1160.47.42004 Boehringer Ingelheim Investigational Site
City
Praha 2
Country
Czech Republic
Facility Name
1160.47.42014 Boehringer Ingelheim Investigational Site
City
Tabor
Country
Czech Republic
Facility Name
1160.47.42010 Boehringer Ingelheim Investigational Site
City
Usti nad Labem
Country
Czech Republic
Facility Name
1160.47.42007 Boehringer Ingelheim Investigational Site
City
Zlin
Country
Czech Republic
Facility Name
1160.47.45008 Boehringer Ingelheim Investigational Site
City
Esbjerg
Country
Denmark
Facility Name
1160.47.45009 Boehringer Ingelheim Investigational Site
City
Holbæk
Country
Denmark
Facility Name
1160.47.45002 Boehringer Ingelheim Investigational Site
City
Kolding
Country
Denmark
Facility Name
1160.47.45004 Boehringer Ingelheim Investigational Site
City
København NV
Country
Denmark
Facility Name
1160.47.45007 Boehringer Ingelheim Investigational Site
City
København S
Country
Denmark
Facility Name
1160.47.45006 Boehringer Ingelheim Investigational Site
City
Slagelse
Country
Denmark
Facility Name
1160.47.35804 Boehringer Ingelheim Investigational Site
City
Espoo
Country
Finland
Facility Name
1160.47.35801 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
1160.47.35802 Boehringer Ingelheim Investigational Site
City
Jyväskylä
Country
Finland
Facility Name
1160.47.35805 Boehringer Ingelheim Investigational Site
City
Kuopio
Country
Finland
Facility Name
1160.47.35803 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
1160.47.3301A Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301B Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301C Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301D Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301E Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301F Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301H Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3301I Boehringer Ingelheim Investigational Site
City
Brest Cedex
Country
France
Facility Name
1160.47.3302A Boehringer Ingelheim Investigational Site
City
Lorient
Country
France
Facility Name
1160.47.3303A Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.47.3303B Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.47.3303C Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.47.3303D Boehringer Ingelheim Investigational Site
City
St Etienne Cedex 2
Country
France
Facility Name
1160.47.3308A Boehringer Ingelheim Investigational Site
City
Vandoeuvre les Nancy
Country
France
Facility Name
1160.47.49017 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.47.49018 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1160.47.49003 Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
1160.47.49005 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1160.47.49006 Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
1160.47.49007 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1160.47.49008 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1160.47.49009 Boehringer Ingelheim Investigational Site
City
Püttlingen
Country
Germany
Facility Name
1160.47.30001 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1160.47.30006 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1160.47.30007 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1160.47.30009 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1160.47.36001 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.47.36006 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.47.36007 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
1160.47.36002 Boehringer Ingelheim Investigational Site
City
Debrecen
Country
Hungary
Facility Name
1160.47.36012 Boehringer Ingelheim Investigational Site
City
Gyula
Country
Hungary
Facility Name
1160.47.36004 Boehringer Ingelheim Investigational Site
City
Miskolc
Country
Hungary
Facility Name
1160.47.36003 Boehringer Ingelheim Investigational Site
City
Pecs
Country
Hungary
Facility Name
1160.47.36011 Boehringer Ingelheim Investigational Site
City
Szombathely
Country
Hungary
Facility Name
1160.47.36010 Boehringer Ingelheim Investigational Site
City
Székesfehérvár
Country
Hungary
Facility Name
1160.47.91002 Boehringer Ingelheim Investigational Site
City
Ahmedabad
Country
India
Facility Name
1160.47.91011 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1160.47.91015 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1160.47.91012 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1160.47.91017 Boehringer Ingelheim Investigational Site
City
Chennai
Country
India
Facility Name
1160.47.91009 Boehringer Ingelheim Investigational Site
City
Madurai
Country
India
Facility Name
1160.47.91007 Boehringer Ingelheim Investigational Site
City
Mysore
Country
India
Facility Name
1160.47.91003 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1160.47.91006 Boehringer Ingelheim Investigational Site
City
new Delhi
Country
India
Facility Name
1160.47.91010 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1160.47.91001 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.47.91005 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.47.91008 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.47.91014 Boehringer Ingelheim Investigational Site
City
Trivandrum
Country
India
Facility Name
1160.47.91004 Boehringer Ingelheim Investigational Site
City
Vadodara
Country
India
Facility Name
1160.47.97202 Boehringer Ingelheim Investigational Site
City
Afula
Country
Israel
Facility Name
1160.47.97207 Boehringer Ingelheim Investigational Site
City
Ashkelon
Country
Israel
Facility Name
1160.47.97211 Boehringer Ingelheim Investigational Site
City
Haifa
Country
Israel
Facility Name
1160.47.97203 Boehringer Ingelheim Investigational Site
City
Holon
Country
Israel
Facility Name
1160.47.97205 Boehringer Ingelheim Investigational Site
City
Kfar Saba
Country
Israel
Facility Name
1160.47.97206 Boehringer Ingelheim Investigational Site
City
Petach Tikva
Country
Israel
Facility Name
1160.47.97208 Boehringer Ingelheim Investigational Site
City
Rehovot
Country
Israel
Facility Name
1160.47.97210 Boehringer Ingelheim Investigational Site
City
Tel Aviv
Country
Israel
Facility Name
1160.47.97204 Boehringer Ingelheim Investigational Site
City
Tel Hashomer
Country
Israel
Facility Name
1160.47.97201 Boehringer Ingelheim Investigational Site
City
Zerifin
Country
Israel
Facility Name
1160.47.39003 Boehringer Ingelheim Investigational Site
City
Bologna
Country
Italy
Facility Name
1160.47.39004 Boehringer Ingelheim Investigational Site
City
Cremona
Country
Italy
Facility Name
1160.47.39006 Boehringer Ingelheim Investigational Site
City
Genova
Country
Italy
Facility Name
1160.47.39008 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1160.47.39007 Boehringer Ingelheim Investigational Site
City
Reggio Emilia
Country
Italy
Facility Name
1160.47.39009 Boehringer Ingelheim Investigational Site
City
Udine
Country
Italy
Facility Name
1160.47.39005 Boehringer Ingelheim Investigational Site
City
Vittorio Veneto
Country
Italy
Facility Name
1160.47.52036 Boehringer Ingelheim Investigational Site
City
Chihuahua
Country
Mexico
Facility Name
1160.47.52039 Boehringer Ingelheim Investigational Site
City
Culiacan
Country
Mexico
Facility Name
1160.47.52030 Boehringer Ingelheim Investigational Site
City
Guadalajara, Jal.
Country
Mexico
Facility Name
1160.47.52027 Boehringer Ingelheim Investigational Site
City
Monterrey
Country
Mexico
Facility Name
1160.47.52034 Boehringer Ingelheim Investigational Site
City
San Luis Potosí
Country
Mexico
Facility Name
1160.47.31001 Boehringer Ingelheim Investigational Site
City
Amersfoort
Country
Netherlands
Facility Name
1160.47.31006 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.47.31007 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.47.31010 Boehringer Ingelheim Investigational Site
City
Den Bosch
Country
Netherlands
Facility Name
1160.47.31014 Boehringer Ingelheim Investigational Site
City
Heerlen
Country
Netherlands
Facility Name
1160.47.31005 Boehringer Ingelheim Investigational Site
City
Maastricht
Country
Netherlands
Facility Name
1160.47.31004 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1160.47.31009 Boehringer Ingelheim Investigational Site
City
Rotterdam
Country
Netherlands
Facility Name
1160.47.64004 Boehringer Ingelheim Investigational Site
City
Christchurch
Country
New Zealand
Facility Name
1160.47.64003 Boehringer Ingelheim Investigational Site
City
Grafton
Country
New Zealand
Facility Name
1160.47.64002 Boehringer Ingelheim Investigational Site
City
Otahuhu
Country
New Zealand
Facility Name
1160.47.64001 Boehringer Ingelheim Investigational Site
City
Takapuna Auckland 9
Country
New Zealand
Facility Name
1160.47.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1160.47.47004 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
1160.47.47003 Boehringer Ingelheim Investigational Site
City
Rud
Country
Norway
Facility Name
1160.47.47005 Boehringer Ingelheim Investigational Site
City
Trondheim
Country
Norway
Facility Name
1160.47.48004 Boehringer Ingelheim Investigational Site
City
Kielce
Country
Poland
Facility Name
1160.47.48005 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.47.48007 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.47.48003 Boehringer Ingelheim Investigational Site
City
Poznan
Country
Poland
Facility Name
1160.47.48006 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.47.35104 Boehringer Ingelheim Investigational Site
City
Almada
Country
Portugal
Facility Name
1160.47.35109 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1160.47.35107 Boehringer Ingelheim Investigational Site
City
Covilhã
Country
Portugal
Facility Name
1160.47.35101 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1160.47.35102 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1160.47.35105 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1160.47.07022 Boehringer Ingelheim Investigational Site
City
Belgorod
Country
Russian Federation
Facility Name
1160.47.07011 Boehringer Ingelheim Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
1160.47.07021 Boehringer Ingelheim Investigational Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
1160.47.07007 Boehringer Ingelheim Investigational Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
1160.47.07016 Boehringer Ingelheim Investigational Site
City
Krasnodar
Country
Russian Federation
Facility Name
1160.47.07004 Boehringer Ingelheim Investigational Site
City
Kursk
Country
Russian Federation
Facility Name
1160.47.07010 Boehringer Ingelheim Investigational Site
City
Novosibirsk
Country
Russian Federation
Facility Name
1160.47.07020 Boehringer Ingelheim Investigational Site
City
Omsk
Country
Russian Federation
Facility Name
1160.47.07018 Boehringer Ingelheim Investigational Site
City
Pskov
Country
Russian Federation
Facility Name
1160.47.07009 Boehringer Ingelheim Investigational Site
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
1160.47.07023 Boehringer Ingelheim Investigational Site
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
1160.47.07024 Boehringer Ingelheim Investigational Site
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
1160.47.07025 Boehringer Ingelheim Investigational Site
City
Rostov-na-Donu
Country
Russian Federation
Facility Name
1160.47.07001 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1160.47.07002 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1160.47.07017 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1160.47.07019 Boehringer Ingelheim Investigational Site
City
Tyumen
Country
Russian Federation
Facility Name
1160.47.07014 Boehringer Ingelheim Investigational Site
City
Ufa
Country
Russian Federation
Facility Name
1160.47.07005 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1160.47.07006 Boehringer Ingelheim Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
1160.47.42107 Boehringer Ingelheim Investigational Site
City
Banska Bystrica
Country
Slovakia
Facility Name
1160.47.42106 Boehringer Ingelheim Investigational Site
City
Lucenec
Country
Slovakia
Facility Name
1160.47.42102 Boehringer Ingelheim Investigational Site
City
Nitra
Country
Slovakia
Facility Name
1160.47.42103 Boehringer Ingelheim Investigational Site
City
Nove Zamky
Country
Slovakia
Facility Name
1160.47.42104 Boehringer Ingelheim Investigational Site
City
Zilina
Country
Slovakia
Facility Name
1160.47.27001 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
1160.47.27002 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
1160.47.27006 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
1160.47.27007
City
Pretoria
Country
South Africa
Facility Name
1160.47.27003 Boehringer Ingelheim Investigational Site
City
Randburg
Country
South Africa
Facility Name
1160.47.27005 Boehringer Ingelheim Investigational Site
City
Roodepoort
Country
South Africa
Facility Name
1160.47.34006 Boehringer Ingelheim Investigational Site
City
Alicante
Country
Spain
Facility Name
1160.47.34012 Boehringer Ingelheim Investigational Site
City
Badalona (Barcelona)
Country
Spain
Facility Name
1160.47.34001 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.47.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.47.34007 Boehringer Ingelheim Investigational Site
City
Cartagena. Murcia
Country
Spain
Facility Name
1160.47.34003 Boehringer Ingelheim Investigational Site
City
Cuenca
Country
Spain
Facility Name
1160.47.34009 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.47.34004 Boehringer Ingelheim Investigational Site
City
Santander
Country
Spain
Facility Name
1160.47.34011 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1160.47.46002 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.47.46006 Boehringer Ingelheim Investigational Site
City
Jönköping
Country
Sweden
Facility Name
1160.47.46001 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.47.46007 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.47.46008 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.47.46005 Boehringer Ingelheim Investigational Site
City
Sundsvall
Country
Sweden
Facility Name
1160.47.46003 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1160.47.90003 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1160.47.90004 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1160.47.90005 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1160.47.90001 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.47.90002 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.47.90007 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1160.47.90006 Boehringer Ingelheim Investigational Site
City
Izmir
Country
Turkey
Facility Name
1160.47.38002 Boehringer Ingelheim Investigational Site
City
Kharkov
Country
Ukraine
Facility Name
1160.47.38006 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1160.47.38005 Boehringer Ingelheim Investigational Site
City
Vinnitsa
Country
Ukraine
Facility Name
1160.47.38003 Boehringer Ingelheim Investigational Site
City
Zaporozhye
Country
Ukraine
Facility Name
1160.47.44005 Boehringer Ingelheim Investigational Site
City
Headington, Oxford
Country
United Kingdom
Facility Name
1160.47.44009 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1160.47.44011 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1160.47.44006 Boehringer Ingelheim Investigational Site
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
1160.47.44012 Boehringer Ingelheim Investigational Site
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27807306
Citation
Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.
Results Reference
derived
PubMed Identifier
24081972
Citation
Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
Results Reference
derived
PubMed Identifier
23425163
Citation
Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.47_U10-2533-01-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.47_Literature.pdf
Description
Related Info

Learn more about this trial

Secondary Prevention of Venous Thrombo Embolism (VTE).

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